EXHIBIT 10.19(c)
CONFIDENTIAL TREATMENT REQUESTED: CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE
BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION.
AMENDMENT TWO
TO
LIMITED EXCLUSIVE
PATENT, COPYRIGHT AND
TRADEMARK LICENSE AGREEMENT
FOR
PEREGRINE(TM) DOSE CALCULATION SYSTEM
FOR RADIATION TREATMENT PLANNING
BETWEEN
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
AND
NOMOS CORPORATION
LLNL CASE NO. TL-1613-99
▇▇▇▇▇▇▇▇ LIVERMORE NATIONAL LABORATORY
UNIVERSITY OF CALIFORNIA
▇.▇. ▇▇▇ ▇▇▇, ▇-▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
INDUSTRIAL PARTNERSHIPS AND COMMERCIALIZATION
JUNE 2002
CONFIDENTIAL TREATMENT
AMENDMENT TWO
NOMOS Corporation Radiation Treatment Planning
Amendment Two
--------------------------------------------------------------------------------
AMENDMENT TWO
June 2002
to
License Agreement - LLNL Case Number TL-1613-99
For PEREGRINE(TM) DOSE CALCULATION SYSTEM
For Radiation Treatment Planning
between NOMOS Corporation and
The Regents of the University of California
effective July 20, 1999
This Amendment Two to the License Agreement by and between The Regents of the
University of California ("THE REGENTS") and NOMOS Corporation ("LICENSEE")
will be effective as of the date of execution of this Amendment by both
Parties. This Amendment and the associated License Agreement are subject to
overriding obligations to the Federal Government pursuant to the provisions of
THE REGENTS' Contract No. W-7405-ENG-48 with the United States Department of
Energy ("DOE") for the operation of the ▇▇▇▇▇▇▇▇ Livermore National Laboratory
("LLNL").
This Amendment Two will modify the field of use, some performance obligations,
and royalty fees as reflected in the amended Exhibits B (RIGHTS GRANTED AND
PERFORMANCE OBLIGATIONS) and C (FEES AND ROYALTIES). All other terms and
conditions remain the same.
Therefore, in consideration of the mutual covenants and obligations recited
herein, THE REGENTS and LICENSEE hereby amend the License Agreement as follows:
1. EXHIBIT B (RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS) AND EXHIBIT C (FEES
AND ROYALTIES) are replaced in their entirety as follows:
--------------------------------------------------------------------------------
1
CONFIDENTIAL TREATMENT
AMENDMENT TWO
NOMOS Corporation Radiation Treatment Planning
Amendment Two
--------------------------------------------------------------------------------
EXHIBIT B - RIGHTS GRANTED AND PERFORMANCE OBLIGATIONS
NOTICE
------
LICENSEE CONSIDERS INFORMATION IN THIS EXHIBIT B TO BE PROPRIETARY.
B.1 RIGHTS GRANTED
B.1.1 Rights to Licensed Patents
Subject to the limitations set forth in this Agreement, THE REGENTS
hereby grants to LICENSEE an exclusive, nontransferable,
royalty-bearing license to: 1) make, have made, use, sell, offer
for sale, and import Licensed Products in the Field of Use, and b)
practice Licensed Methods in the Field of Use.
B.1.2 Rights to Licensed Copyrights
Subject to the terms and conditions of this Agreement, THE REGENTS
grants to LICENSEE an exclusive, nontransferable, royalty-bearing
license to duplicate, display, perform, make Derivative Works,
distribute and have distributed, and sell Licensed Products covered
by Licensed Copyrights in the Field of Use.
B.1.3 Rights to Licensed Trademarks
Subject to the terms and conditions of this Agreement, THE REGENTS
hereby grants LICENSEE an exclusive license to use Licensed
Trademarks, in corresponding Territories, as specified in Exhibit E
(LICENSED TRADEMARKS), on Licensed Products or for Licensed Methods
in the Field of Use.
--------------------------------------------------------------------------------
2
CONFIDENTIAL TREATMENT
AMENDMENT TWO
NOMOS Corporation Radiation Treatment Planning
Amendment Two
--------------------------------------------------------------------------------
B.1.4 "Field of Use" means planning human and animal cancer
therapies based on tumor radiation with photons or electrons
that are generated either by a radiation source external to
the patient (teletherapy) or an encapsulated radiation
source internal to the patient (brachytherapy).
B.2 SUBLICENSING RIGHTS
THE REGENTS also grants to LICENSEE the right to issue royalty-bearing
sublicenses to third parties in the Field of Use, having rights no
greater than those granted to LICENSEE, provided that LICENSEE has
exclusive rights in such Licensed Patents, Licensed Copyrights, and
Licensed Trademarks in the Field of Use at the time of sublicensing.
LICENSEE may issue sublicenses to Licensed Trademarks only in
conjunction with LICENSEE's sublicensing of Licensed Patents and
Licensed Copyrights.
A Use Sublicense is considered to be a Licensed Product and not a
sublicense as contemplated in this B.2.
B.3 RIGHTS EXCLUDED
Rights that are not specifically granted in this Exhibit B or
elsewhere in this Agreement are specifically excluded from the
license. In particular, no license, express or implied, is granted to
LICENSEE to Licensed Trademarks outside the corresponding Territory as
specified in Exhibit E (LICENSED TRADEMARKS).
B.4 FUTURE RIGHTS
Licensable WFO Subject Inventions and Licensable WFO Computer Software
will be added to Exhibit A by amendment.
--------------------------------------------------------------------------------
3
CONFIDENTIAL TREATMENT
AMENDMENT TWO
NOMOS Corporation Radiation Treatment Planning
Amendment Two
--------------------------------------------------------------------------------
B.5 PERFORMANCE OBLIGATIONS
B.5.1 LICENSEE will proceed diligently to develop, file relevant
regulatory applications for and attempt to obtain relevant
regulatory commercialization approvals with respect to the
manufacturing, marketing, and sale of Licensed Products for all
uses in the Field of Use. LICENSEE will file with the U.S. Food
and Drug Administration at least one 510k Application or PMA
(Pre-Market Approval) for clearance of Licensed Products for at
least teletherapy uses within one (1) year of the Effective Date.
Notwithstanding any other term of this Agreement, for the
purposes of (a) invoking/complying with the ▇▇▇▇▇-▇▇▇▇▇▇ Act (35
U.S.C. Section 156) and any corresponding rules and regulations
of the U.S. Patent & Trademark Office regarding patent term
extension, and (b) seeking regulatory approval of LICENSEE's
Licensed Products and Licensed Methods, LICENSEE shall act as THE
REGENTS' agent. To the extend deemed necessary by LICENSEE, in
good faith, the Parties will cooperate to secure regulatory
approval of LICENSEE's Licensed Products and Licensed Methods.
B.5.2 LICENSEE will release for distribution and offer Sales of
Licensed Products by the later date of either October 1, 2000, or
within sixty (60) days after the date of FDA clearance for
teletherapy uses of Licensed Products.
B.5.3 LICENSEE will have gross revenues from Sales of Licensed Products
or use of Licensed Methods of at least [***] per calendar year,
as measured at the close of LICENSEE'S business on December 31 of
the relevant calendar year, commencing with the later of
---------------
***Confidential material redacted and filed separately with the Commission.
--------------------------------------------------------------------------------
4
CONFIDENTIAL TREATMENT
AMENDMENT TWO
Radiation Treatment Planning
NOMOS Corporation Amendment Two
--------------------------------------------------------------------------------
calendar year 2004, or the first full calendar year after a
Licensed Product has been released for distribution and offered
for sale in accordance with paragraph B.5.2.
B.5.4 LICENSEE will release for distribution and offer first OEM sale of
Licensed Products that interface with radiation treatment planning
systems that are manufactured and sold, or otherwise distributed
to third parties, by entities other than LICENSEE by the later
date of either October 1, 2001, or one year after initial release
for distribution and offer of Sales of Licensed Products as
defined in B.5.2. To the extent that some commercial entities may
prefer to sublicense Licensed Patents and Licensed Copyrights
rather than to purchase Licensed Products on an OEM basis,
LICENSEE's sublicenses may satisfy this OEM performance
obligation.
B.5.5 LICENSEE will release for distribution and offer first sale of
Licensed Products in the Field of Use for brachytherapy by the
later date of either [***], or within sixty (60) days after the
date of FDA clearance for brachytherapy uses of Licensed Products.
B.5.6 LICENSEE will release for distribution and offer first sale of
Licensed Products in the Field of Use for inverse treatment
planning by the later date of either [***], or within sixty (60)
days after the date of FDA clearance for inverse treatment
planning uses of Licensed Products.
B.5.7 LICENSEE will release for distribution and offer first sale of
Licensed Products in the Field of Use for electron radiotherapy by
the later date of either [***], or within sixty (60) days after
the date of FDA clearance for electron radiotherapy uses of
Licensed Products.
---------------
***Confidential material redacted and filed separately with the Commission.
--------------------------------------------------------------------------------
5
CONFIDENTIAL TREATMENT
AMENDMENT TWO
Radiation Treatment Planning
NOMOS Corporation Amendment Two
--------------------------------------------------------------------------------
B.5.8 The sales and other performance requirements specified above may,
by mutual written consent of LICENSEE and THE REGENTS, be amended
and/or extended at the written request of LICENSEE to THE REGENTS,
based upon legitimate business or technical reasons specified in
reasonable detail in such written request. THE REGENTS will not
unreasonably withhold its consent to requests made in accordance
with this paragraph.
B.5.9 The first progress report will be due on February 28, 2000.
--------------------------------------------------------------------------------
6
CONFIDENTIAL TREATMENT
AMENDMENT TWO
NOMOS Corporation Radiation Treatment Planning
Amendment Two
--------------------------------------------------------------------------------
EXHIBIT C - FEES AND ROYALTIES
NOTICE
------
LICENSEE CONSIDERS INFORMATION IN THIS EXHIBIT C TO BE PROPRIETARY.
C.1 LICENSE ISSUE FEE
C.1.1 As partial consideration for this Agreement, LICENSEE will pay to
THE REGENTS a nonrefundable issue fee of [***] (License Issue Fee)
as follows:
C.1.1.1 [***] to be paid when LICENSEE executes the Agreement.
C.1.1.2 [***] to be paid no later than October 1, 1999.
C.1.1.3 [***] to be paid no later than November 1, 1999.
C.1.1.4 [***] to be paid no later than December 1, 1999.
C.1.1.5 [***] to be paid no later than January 1, 2000.
C.1.1.6 [***] to be paid no later than February 1, 2000.
C.1.2 THE REGENTS will execute the Agreement after receipt of LICENSEE's
executed copies of the Agreement and payment of the first
installment of the License Issue Fee specified in C.1.1.1 above.
---------------
***Confidential material redacted and filed separately with the Commission.
--------------------------------------------------------------------------------
7
CONFIDENTIAL TREATMENT
AMENDMENT TWO
NOMOS Corporation Radiation Treatment Planning
Amendment Two
--------------------------------------------------------------------------------
C.1.3 The License Issue Fee will not be credited against any other
royalty or fee due from LICENSEE to THE REGENTS.
C.1.4 In the event that LICENSEE grants sublicenses, LICENSEE will
collect an issue fee equal to or greater than the License
Issue Fee. LICENSEE will pay to THE REGENTS [***] of any
issue fee from sublicensing.
C.2. EARNED ROYALTIES
In addition to the License Issue Fee, LICENSEE will pay THE REGENTS an
earned royalty equal to [***] of Net Sales by LICENSEE and any
sublicensees. The earned royalty on sales of any Licensed Product that
is sold as part of a larger product system, shall be based on the
average Net Sales of that Licensed Product sold separately on a non-OEM
basis over the relevant royalty reporting period. For the purposes of
calculating earned royalties, the minimum value of any License Product
shall be [***] for the first two (2) full years after the date of
initial release for distribution and offer of Sales of Licensed
Products as specified in B.5.2. The minimum value shall be [***] for
the next two (2) full years, and [***] thereafter.
Payments of earned royalties will be in accordance with the
requirements of Article 4.2 (SUBLICENSING RIGHTS AND OBLIGATIONS),
Article 5 (FEES, ROYALTIES AND PAYMENTS) and Article 7 (PROGRESS AND
ROYALTY REPORTS) of this Agreement.
---------------
***Confidential material redacted and filed separately with the Commission.
--------------------------------------------------------------------------------
8
CONFIDENTIAL TREATMENT
AMENDMENT TWO
NOMOS Corporation Radiation Treatment Planning
Amendment Two
--------------------------------------------------------------------------------
C.3 MINIMUM ANNUAL ROYALTIES
LICENSEE will pay to THE REGENTS a minimum annual royalty according to the
requirements of Article 5 (FEES, ROYALTIES AND PAYMENTS) and the schedule
below. Earned royalties paid to THE REGENTS for Net Sales during a calendar
year will be accrued and credited against the minimum annual royalty paid for
that same calendar year.
--------------------------------------------------------------------------------
CALENDAR YEAR MINIMUM ANNUAL DUE DATE IN CALENDAR
ROYALTY YEAR
--------------------------------------------------------------------------------
2000 [***] February 28
--------------------------------------------------------------------------------
2001 [***] February 28
--------------------------------------------------------------------------------
2002 [***] of cumulative February 28
annual revenue* sales
up to [***]
[***] of cumulative
annual revenue sales
greater than [***]
but less than
[***]
[***] of cumulative
annual revenue sales
greater than
[***]
--------------------------------------------------------------------------------
2003 Same as 2002 February 28
--------------------------------------------------------------------------------
2004 [***] February 28
--------------------------------------------------------------------------------
2005 and thereafter for the [***] February 28
life of this Agreement
--------------------------------------------------------------------------------
* As used herein, the term "cumulative annual revenue" means any revenue
generated from sales of the Licensed Products or use of the Licensed Methods,
accumulated or realized during the period January 1 to December 31 of a given
year, in this instance, the years 2002, and 2003.
---------------
***Confidential material redacted and filed separately with the Commission.
--------------------------------------------------------------------------------
9
CONFIDENTIAL TREATMENT
AMENDMENT TWO
NOMOS Corporation Radiation Treatment Planning
Amendment Two
--------------------------------------------------------------------------------
THE REGENTS and LICENSEE execute this Amendment, in duplicate originals, by
their respective officers who are duly authorized on the day and year that is
written.
NOMOS CORPORATION THE REGENTS OF THE
UNIVERSITY OF CALIFORNIA
▇▇▇▇▇▇▇▇ LIVERMORE
NATIONAL LABORATORY
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
--------------------------------- -------------------------------
(Signature) (Signature)
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
------------------------------- -----------------------------
Title: VP - Engineering & Development Title: Director, IPAC
------------------------------ ---------------------------
Date signed: June 3 , 2002 Date signed: June 4 , 2002
-------------------- ----------------
--------------------------------------------------------------------------------
10